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LYRICA® CR, CV (pregabalin extended-release)

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LYRICA® CR, CV Quick Finder

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HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use LYRICA CR safely and effectively. See full prescribing information for LYRICA CR.

LYRICA® CR (pregabalin) extended-release tablets, for oral use, CV
Initial U.S. Approval: 2004

RECENT MAJOR CHANGES

Warnings and Precautions, Respiratory Depression (5.4) 4/2020
Warnings and Precautions, Concomitant Use with Opioids (5.14) 6/2019

INDICATIONS AND USAGE

LYRICA CR is indicated for the management of:

  • Neuropathic pain associated with diabetic peripheral neuropathy (DPN) (1)
  • Postherpetic neuralgia (PHN) (1)

Efficacy of LYRICA CR has not been established for the management of fibromyalgia or as adjunctive therapy for adult patients with partial onset seizures.

DOSAGE AND ADMINISTRATION

  • LYRICA CR should be administered once daily after an evening meal. It should be swallowed whole and should not be split, crushed, or chewed. (2.1)
  • Dosing recommendations for LYRICA CR:
Indication Dosing Regimen Initial Dose Maximum Dose
DPN Pain (2.2) Single dose per day 165 mg/day 330 mg/day within 1 week.
PHN (2.3) Single dose per day 165 mg/day 330 mg/day within 1 week. Maximum dose of 660 mg/day.
  • Conversion from LYRICA Capsules or Oral Solution to LYRICA CR: See full prescribing information. (2.4)
  • Dose modification recommended in patients with renal impairment. (2.5)

DOSAGE FORMS AND STRENGTHS

Extended-release tablets: 82.5 mg, 165 mg, and 330 mg. (3)

CONTRAINDICATIONS

Known hypersensitivity to pregabalin or any of its components. (4)

WARNINGS AND PRECAUTIONS

  • Angioedema: Angioedema [e.g., swelling of the face, mouth (tongue, lips, and gums) and neck (throat and larynx)] can occur and may be associated with life-threatening respiratory compromise requiring emergency treatment. Discontinue LYRICA CR immediately in patients with these symptoms. (5.1)
  • Hypersensitivity reactions: Hypersensitivity reactions (e.g., hives, dyspnea, and wheezing) can occur. Discontinue LYRICA CR immediately in these patients. (5.2)
  • Suicidal Behavior and Ideation: Antiepileptic drugs, including pregabalin, the active ingredient in LYRICA CR, increase the risk of suicidal thoughts or behavior. (5.3)
  • Respiratory Depression: May occur with LYRICA when used with concomitant CNS depressants or in the setting of underlying respiratory impairment. Monitor patients and adjust dosage as appropriate. (5.4)
  • Dizziness and Somnolence: May cause dizziness and somnolence and impair patients ability to drive or operate machinery. (5.5)
  • Increased seizure frequency may occur in patients with seizure disorders if LYRICA CR is rapidly discontinued. Withdraw LYRICA CR gradually over a minimum of 1 week. (5.6)
  • Peripheral Edema: May cause peripheral edema. Monitor patients for the development of edema when co-administering LYRICA CR and thiazolidinedione antidiabetic agents. (5.7)

ADVERSE REACTIONS

Most common adverse reactions reported in greater than or equal to 4% of patients treated with LYRICA CR are dizziness, somnolence, headache, fatigue, peripheral edema, nausea, blurred vision, dry mouth, and weight gain. (6.1)


To report SUSPECTED ADVERSE REACTIONS, contact Pfizer, Inc. at (800) 438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

USE IN SPECIFIC POPULATIONS

  • Pregnancy: May cause fetal harm. Advise of potential risk to the fetus. (8.1)
  • Lactation: Breastfeeding is not recommended. (8.2)

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 4/2020

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Report Adverse Event

Contact Pfizer Safety to report an adverse event, side effect or concern about the quality of a Pfizer product: (800) 438-1985

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns at 1-800-FDA-1088 or www.fda.gov/MedWatch